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Exalgo (Generic Hydromorphone)

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Hydromorphone use has the potential to develop into a habit, especially over time. Follow the hydromorphone directions exactly. Do not take it in larger amounts, more frequently, or otherwise differently than prescribed by your doctor. Discuss your pain management objectives, course of treatment, and additional pain management options with your healthcare provider while you are taking hydromorphone. Inform your doctor if you or any family members regularly consume excessive amounts of alcohol, engage in drug usage (including street drugs), misuse prescription drugs, experience overdosing, or suffer from depression or another mental disease. If any of these disorders exist or have ever existed in your body, you are more likely to misuse hydromorphone. If you suspect an opioid addiction, speak with your doctor right away and ask for advice. You can also contact the SAMHSA National Helpline by calling 1-800-662-HELP.

Breathing issues from hydromorphone may be severe or even fatal, particularly in the first 24 to 72 hours of treatment and whenever the dose is raised. Throughout your therapy, your doctor will keep a close eye on you. If you experience delayed breathing or asthma now or in the past, let your doctor know. Most likely, your doctor will advise against taking hydromorphone. A head injury, a brain tumour, any condition that raises the pressure inside your brain, kyphoscoliosis, or any other lung ailment, such as chronic obstructive pulmonary disease (a group of disorders that affect the lungs and airways), should also be disclosed to your doctor (curving of the spine that may cause breathing problems). If you are older, weaker, or malnourished as a result of a condition, your risk of developing respiratory issues may increase. Get emergency medical care if you encounter any of the following symptoms, or call your doctor right away: sluggish breathing, protracted breath gaps, or shortness of breath.

The chance of developing severe or life-threatening respiratory issues, sedation, or coma while receiving hydromorphone treatment may rise if you take certain drugs. Benzodiazepines, such as estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion), medications for mental illness or nausea, muscle relaxants, other narcotic pain medications, sedatives, sleeping pills, or tranquillizers are all things you should discuss with your doctor if you are currently taking them or intend to start taking them. Your doctor will closely monitor you and may need to adjust the dosage of your drugs. Call your doctor right away if you experience any of the following symptoms while taking hydromorphone with any of these drugs: unusual dizziness, lightheadedness, excessive drowsiness, slowed or laboured breathing, or inability to respond. If you are unable to seek treatment on your own, make sure your carer or family members are aware of any symptoms that may be dangerous so they can contact the doctor or emergency services.

You run a higher chance of developing severe, potentially fatal adverse effects from hydromorphone treatment if you consume alcohol, use prescription or over-the-counter medications that do, or use illicit substances. During your treatment, refrain from drinking alcohol, taking alcohol-containing prescription or over-the-counter medications, or using illegal substances.

Completely swallow the extended-release pills. Avoid breaking, chewing, dissolving, or crushing them. You run the risk of taking too much hydromorphone at once if you ingest broken, chewed, crushed, or dissolved pills as opposed to taking the medicine gradually over time. Death or severe respiratory issues may result from this.

Do not share your medication with anybody else. Some people who take your drug, especially children, may suffer injury or even pass away from hydromorphone. Store hydromorphone in a secure location to prevent accidental or intentional consumption by others. Take extra care to keep hydromorphone out of children’s reach. Count the remaining pills or liquid so you’ll know if any prescriptions are missing. Extensive-release tablets, fluids, and unwanted or no longer required tablets should all be flushed down the toilet. (See DISPOSAL and STORAGE.)

If you are pregnant or want to become pregnant, let your doctor know. Regular hydromorphone use during pregnancy increases the risk of your unborn child developing potentially fatal withdrawal symptoms. If your infant exhibits any of the following symptoms, contact your doctor straight away: irritability, hyperactivity, disturbed sleep, high-pitched crying, excessive shaking of a body part, vomiting, diarrhoea, or failure to gain weight.

The manufacturer’s patient information sheet (Medication Guide) will be sent to you by your doctor or chemist when you start your hydromorphone medication and each time you fill your prescription. If you have any questions, carefully read the information and ask your doctor or chemist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (

Discuss the dangers of using hydromorphone with your doctor.

Why is this medication prescribed?

To treat pain, people turn to hydromorphone. Those who are likely to require pain medication 24 hours a day for a prolonged period of time and who are unable to be treated with other medications can use hydromorphone extended-release tablets to relieve their severe pain. Only those who have been taking opioid medications for at least one week should use hydromorphone extended-release tablets to treat pain; they should not be used to treat mild to moderate pain, short-term pain, pain following an operation or other medical or dental procedure, or pain that can be managed with medication taken only as needed. The class of drugs known as opiate (narcotic) analgesics includes hydromorphone. It functions by altering how the nerve system and brain react to pain.

How should this medicine be used?

There are three oral dosage forms of hydromorphone: a liquid, a tablet, and an extended-release (long-acting) tablet. The tablets are typically taken every 4 to 6 hours, whereas the liquid is typically given every 3 to 6 hours. The once-daily extended-release tablets may be taken with or without food. Take hydromorphone every day at about the same time(s). Ask your doctor or chemist to explain any instructions on your prescription label that you are unsure about following. Follow the hydromorphone directions exactly.

Do not let your skin or clothing come in contact with the hydromorphone liquid. If such contact occurs, take off any clothing that was in contact with the oral liquid and thoroughly wash your skin with lukewarm water.

Your doctor might prescribe you a low dose of hydromorphone to start, and then gradually increase it, no more frequently than once every three to four days. If you encounter side effects, your doctor might reduce your dose. If you believe that your pain is not being controlled or if you suffer any negative effects while receiving hydromorphone medication, let your doctor know. Without first consulting your doctor, never alter the dosage of your prescription.

Without consulting your doctor, do not discontinue taking hydromorphone. Your dose will likely be gradually reduced by your doctor. Restlessness, teary eyes, runny noses, yawning, sweating, chills, hair standing on end, muscle or joint pain, widening of the pupils (black circles in the middle of the eyes), irritability, anxiety, backache, weakness, stomach cramps, trouble falling or staying asleep, nausea, loss of appetite, vomiting, diarrhoea, fast breathing, or rapid heartbeat may be withdrawal symptoms if you abruptly stop taking hydromorphone. Your dose will likely be gradually reduced by your doctor. Talk to your doctor before starting the drug again if you stop taking hydromorphone extended-release tablets for more than three days for any reason.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking hydromorphone,

  • If you have an allergy to any of the substances in hydromorphone tablets, solution, or extended-release pills, including sulfites, let your doctor and chemist know right once. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Mention the drugs in the IMPORTANT CAUTION section as well as any of the following: medications for glaucoma, irritable bowel syndrome, Parkinson’s disease, ulcers, and urinary problems; buprenorphine (Buprenex, Butrans, in Suboxone, in Zubsolv, among others); butorphanol; cyclobenzaprine (Amrix); dextromethorphan (found in many cough medications; in Nuedexta); ipratropium (Atrovent); lithium (Lithobid); migraine drugs such sumatriptan (Alsuma, Imitrex, in Treximet), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig); 5HT3 serotonin blockers like alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); mirtazapine (Remeron); nalbuphine; pentazocine (Talwin); selective serotonin-reuptake inhibitors, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); trazodone (Oleptro); serotonin and norepinephrine reuptake inhibitors such desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), milnacipran (Savella), and venlafaxine (Effexor); and tricyclic antidepressants (often known as “mood elevators”), including amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Additionally, let your doctor or pharmacist know if you’re receiving any of the following monoamine oxidase (MAO) inhibitors or if you’ve recently stopped taking any of them: methylene blue, isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Hydromorphone may also interact with a wide range of other drugs, so be sure to let your doctor know about all the drugs you’re taking, even if they don’t appear on this list. The dosage of your drugs may need to be adjusted, and your health may need to be closely watched for any negative effects.
  • Inform your doctor about the herbal supplements you are taking, especially if you take St. John’s wort or tryptophan.
    Inform your doctor if you suffer from any of the ailments detailed in the IMPORTANT CAUTION section, paralytic ileus (a condition in which food does not pass through the intestines), a blockage in the stomach, or gastrointestinal obstruction. Your doctor could advise against taking hydromorphone.
  • If you will be taking the extended-release tablets, inform your doctor if you have ever undergone surgery that altered how food passes through your stomach or intestines or if you have any conditions that cause the oesophagus, stomach, or intestines to become narrow, such as cystic fibrosis (a condition that causes the body to produce thick, sticky mucus that may clog the pancreas, lungs, and other parts of the body), peritonitis (inflammation of the lining of the abdomen (stomach area)), Meckel’s diverticulum (a bulge in the lining of the small intestine present at birth), chronic intestinal pseudo-obstruction (condition in which the muscles in the intestine do not move food through the intestine smoothly), or inflammatory bowel disease (IBD; a group of conditions that cause inflammation of the lining of the intestine) are examples of such conditions. You could be advised by your doctor not to take extended-release pills of hydromorphone.
  • Inform your doctor if your blood pressure is low or has ever been low; the illness known as Addison’s disease, in which the adrenal glands produce less hormone than usual; seizures; any illness that makes it difficult to urinate, like an enlarged prostate (a male reproductive organ) or urethral stricture (a blockage of the tube that permits urine to exit the body); or gallbladder, pancreatic, liver, thyroid, or kidney problems.
  • Describe to your doctor if you are nursing a baby.
  • You should be aware that this medicine may lower both male and female fertility. Discuss the dangers of using hydromorphone with your doctor.
  • Inform the surgeon, including the dentist, if you are undergoing surgery, that you are taking hydromorphone.
  • You ought to be aware that hydromorphone might make you sleepy. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • You should be aware that if you stand up too rapidly from a supine position while taking hydromorphone, you could have dizziness, lightheadedness, and fainting. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.
  • You ought to be aware that hydromorphone might result in constipation. While using hydromorphone, discuss with your doctor whether you should alter your diet or take additional medications to avoid or cure constipation.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Take the missed dose of any tablets or solution as soon as you remember it, if you are taking them. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

Skip the missed dosage if you are using extended-release pills and carry on with your normal dosing regimen. The extended-release pills should not be taken more than once per 24 hours.

What side effects can this medication cause?

Side effects from hydromorphone could exist. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Having trouble falling or staying asleep
  • Dry mouth
  • Lightheadedness
  • Drowsiness
  • Heavy perspiration
  • Back, joint, or muscular pain
  • Abdominal pain
  • Anxiety
  • Flushing
  • Itching
  • Depression

Some adverse effects may be severe. Get emergency medical care or call your doctor right away if you develop any of the following symptoms or any of those in the IMPORTANT WARNING section:

  • Rash
  • Hives
  • Edoema of the lower legs, lower arms, hands, feet, ankles, tongue, lips, mouth, or throat
  • Breathing or swallowing challenges
  • Hoarseness
  • Agitation, hallucinations (hearing voices or seeing things that are not there), disorientation, fever, sweating, shivering, extremely stiff or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Nausea, vomiting, weight loss, anorexia, or lightheadedness
  • Failure to achieve or maintain erection
  • Irregular periods of time
  • Less sexual arousal
  • Seizures
  • Chest ache
  • Extreme somnolence
  • Fainting
  • Feeling dizzy when shifting positions

Further negative consequences of hydromorphone could exist. If you have any strange side effects while taking this medicine, contact your doctor right once.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication out of the reach of children and tightly closed in the original container. Keep it at normal temperature, away from sources of extreme heat and moisture (not in the bathroom). Any drug that is no longer needed or old must be disposed of right away via a medicine take-back programme. If you no longer need any hydromorphone liquid or tablets, flush them down the toilet if there isn’t a take-back programme available to you locally or that you can quickly access. Ask your chemist how to dispose of your medications properly.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

You should speak with your doctor about keeping naloxone, a life-saving drug, on hand while taking hydromorphone (e.g., home, office). Naloxone is used to undo an overdose’s potentially fatal consequences. To treat harmful symptoms brought on by excessive levels of opiates in the blood, it functions by inhibiting the effects of opiates. If you live with young children or someone who has abused prescription or illicit drugs, your doctor could also advise you to get naloxone. Make sure you, your family, your caretakers, and anyone else who spends time with you are aware of the signs of an overdose, how to administer naloxone, and what to do until emergency assistance arrives. You and your family members will be shown how to use the medication by your doctor or chemist. For the directions, speak to your chemist or go to the manufacturer’s website. If you start to experience overdose symptoms, a friend or family member should administer the first dose of naloxone, contact 911 right away, and stay by your side while keeping a careful eye on you until emergency medical assistance comes. After receiving naloxone, your symptoms can come back a short while later. The person should administer you another dose of naloxone if your symptoms come back. If symptoms reappear before receiving medical attention, more doses may be given every 2 to 3 minutes.

Overdose signs could include the following:

  • Shallow or sluggish breathing
  • Having trouble breathing
  • Sleepiness
  • Unable to wake up or speak
  • Muscle tremor
  • Clammy, frigid skin
  • Pupils that are either smaller or larger (dark circles in the middle of the eyes)
  • Sluggish or irregular pulse
  • Dizziness
  • Fainting

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to hydromorphone, your doctor may request specific lab tests.

Inform your doctor and the lab staff that you are taking hydromorphone prior to any laboratory test (particularly one that uses methylene blue).

Tell the x-ray technician that you are taking the extended-release pill if you have any upcoming x-ray procedures.

This medication cannot be renewed. Call your doctor if the discomfort persists after you’ve finished the hydromorphone.

You might find the tablet shell in your stool if you’re using extended release tablets. This is typical and does not imply that you didn’t take the entire drug dose.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Dilaudid®
  • Exalgo®
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